Here at Biostar we offer support and consultancy throughout the medical device development process and always from a regulatory perspective to ensure each phase of the process complies with all the relevant regulations.
We develop each project based on our vast experience and accredited know-how as an expert operator in medical device quality management.
Similarly, we review the regulatory aspects for each project and advise our clients on the best way of fulfilling legislative and quality management requirements in order to obtain the ISO 9001, ISO 13485 and CE certificates.